Four-Arm Randomized Control Trial of Brief MI Versus Couples-Based HIV/STI Prevention in South Africa

HIV Prevention Clinical Trial

— SA R01  

Official title:

Four-Arm RCT of Brief MI vs. Couples-Based HIV/STI Prevention in South Africa

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01554423
• Other study ID #: R01DA029894
• Secondary ID: R01DA029894
• Status: Completed
• Phase: N/A
• First received: February 7, 2012
• Last updated: July 18, 2017
• Start date: July 2010
• Est. completion date: June 30, 2017

Study information

• Verified date: July 2017
• Source: The City College of New York
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study is a Randomized Controlled Trial (RCT) of Integrated and Cognitive Behavioral Therapy for HIV Prevention in Pretoria, South Africa. The RCT will evaluate the efficacy of a brief motivational interview (BMI) and a cognitive-behavioral couples' (IFCBT) intervention alone and in combination against a comparison condition to reduce new cases of HIV and sexually transmitted infections and increase condom use and decrease sexual risk behavior, drug use, and intimate partner violence among young female drug users in Pretoria, South Africa and their primary intimate partners. In the RCT, 384 couples comprised of young female drug users who do (N = 192) and do not (N = 192) trade sex and their primary intimate heterosexual partners will be randomly assigned to one-of-four conditions: (1) testing and counseling; (2) brief motivational interview (BMI); (3) cognitive-behavioral couples' intervention (IFCBT); or (4) BMI and IFCBT combined. Eligibility criteria for couples include an HIV-negative drug using female aged 18 to 40 and their primary intimate partner or spouse who is also HIV negative. Each partner of each couple will be administered assessments with a rapid test for HIV and urine tests for Chlamydia, gonorrhea, trichomoniasis, and drug use at baseline and 3-month, 6-month, and 12-month follow-up.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 464
• Est. completion date: June 30, 2017
• Est. primary completion date: January 31, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

• Live in the Pretoria, South Africa region

• 18-40 Years of Age

• In a steady, intimate relationship for 6 months or longer

• Used illicit drugs in the past 6 months

Exclusion Criteria:

• Acute suicidality/homicidality

Related Conditions & MeSH terms

• HIV Prevention

Intervention

Other:
• Testing and Counseling
Couples will receive information on the transmission and prevention of HIV and STIs, the meaning of test results, and health consequences.

Behavioral:
• Brief Motivational Interview (BMI)
The brief motivational interview (BMI) to be tested in the RCT in Pretoria is a one-session, 45 minute intervention that will coordinate three, 15-minute modules with one module each to (1) reduce hazardous drinking; (2) reduce illicit drug use; and (3) promote condom use.
• Integrated Family and Cognitive Behavioral Therapy
The IFCBT model is 6 sessions in length and coordinates the delivery of 4 cognitive-behavioral group couples' sessions with 2 individual couples' sessions to prevent HIV and STI co-infections among adult drug users. IFCBT targets HIV risk and protective factors that operate across multiple ecological systems. The four group couples' sessions coordinate Rational Emotive Therapy and Problem Solving Therapy strategies to reduce HIV risk behavior and promote protective behaviors. The two individual couples' sessions utilize structural and strategic approaches to promote adaptive communication and shared responsibility for condom use and gender equality and to directly address and reduce any form of abuse between partners when present.

Locations

Country	Name	City	State
South Africa	Louis Pasteur Medical Centre	Pretoria	Gauteng

Sponsors (2)

Lead Sponsor	Collaborator
The City College of New York	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

South Africa, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Biologically confirmed infectious disease status	Biologically confirmed infectious disease (HIV, Chlamydia, gonorrhea, and trichomoniasis)	Outcome measure will be assessed up to 18 months after enrollment.
Primary	Condom use and sexual risk behavior	Condom use during last sexual intercourse, proportion of unprotected sex episodes; number of partners.	Outcome measure will be assessed up to 18 months after enrollment.
Primary	Drug taking risk behavior	Hazardous alcohol use, and positive urinalysis for marijuana, cocaine, heroin.	Outcome measure will be assessed up to 18 months after enrollment.
Primary	Intimate partner violence	Psychological, physical, and sexual violence.	Outcome measure will be assessed up to 18 months after enrollment.